Principal Biostatistician
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials , and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What The Principal Scientist, Biostatistician does at Worldwide
Use independent judgment and technical expertise to assist in designing studies; preparing statistical analysis plans; analyzing data from pharmacokinetic, clinical, andpre‑clinicalstudies; interpreting statistical results from pharmacokinetic, clinical, and related analyses; and generating randomization schedules for clinical studies.
Principal Scientists are recognized as scientific leaders in the company.They regularly contribute to literature and to building Worldwide Clinical Trials ’ intellectual property andare capable of leadinginterdisciplinary project teams.
What you will do
-
Accurately and efficiently perform tasks that are broad in scope
-
Use knowledge and judgment to reachwell‑definedgoals in project management
-
Work independently and collaboratively to solve technical problems by implementing contemporary methods
-
Assistthe clinic, method development, and marketing/business development by applying knowledge, conducting literature reviews, providing information, and offering related support
-
Train and guide less experienced personnel in techniquesrequiredfor work assignments
-
Supervise personnel involved in statistical andpharmacokinetic‑relatedwork
-
Assistwith the design of clinical studies and construct data analysis plans to meet study protocol requirements and maximize information from available data
-
Perform statistical analyses on clinical and pharmacokinetic data usingappropriate methodsand software programs
-
Prepare documentation for final reports, including text, tables, graphs, and analysis outputs
-
Interact with clients, bioanalytical personnel, and clinical personnelregardingstudy design, statistical analyses, pharmacokinetic data analyses, and data interpretation
-
Identifyproblems or potential problems in generating quality statistical and pharmacokinetic documents, report concerns to their supervisor, and proposepossible solutions
-
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are notnecessarilyall‑inclusive.
What your bring to the role
-
Familiarity with corporate policies, goals, andobjectives, normallyacquiredafter three months of exposure to Worldwide Clinical Trials ’operations
-
Understands and applies Good Laboratory Practice (GLP) guidelines and U.S. Food and Drug Administration (FDA) guidance documents pertinent to statistical analysis, pharmacokinetic studies, pharmacokinetic analyses, and reports
- Excellent SAS programming skills
-
Proficient in the use ofWinNonlin,nQuery, Microsoft Word, and Microsoft Excel
-
Ability to read, write, and understand complex literature
-
Ability to wr